Credit: Duke University
This news release provides some useful background about cervical cancer screening and a new device that might make such screenings more accessible around the globe. However, the release is marred by an incomplete description of the steps involved in cervical cancer screening.
Colposcopy (a test that provides an illuminated, magnified view of the cervix) is done not as a primary screening method as suggested here, but rather as a second step in the screening process when an initial screening test is abnormal. The news release is not clear on this point. Primary screening tests for cervical cancer include Pap smears and cervical swabs for human papilloma virus (HPV), or (when those are unavailable) visual inspection of the cervix after acetic acid is applied.
The release tends to exaggerate the potential benefit of this new technology by implying that colposcopy is essential as a primary screening test for all women — when it’s mainly used for the smaller number of women who initially screen positive. Indeed, there is evidence that colposcopy is not effective when used as a primary screening technique in all women.
Mortality from cervical cancer has fallen dramatically in the United States in recent decades due to widespread screening practices, according to the American Cancer Society. In low-income nations and under-served communities, however, cervical cancer still frequently goes undiagnosed. This is largely because diagnostic equipment is expensive and requires highly skilled technicians to administer. This release is on the development of an insertion tool which is used together with a miniaturized digital colposcope to display images of the cervix via laptop or cell phone. The inserter is designed to be a more comfortable alternative to the standard vaginal speculum. either to allow for self-screening with a swab for human papilloma virus (HPV) or diagnostic follow-up for women with abnormal initial screening tests when traditional colposcopy is not available.
This kind of innovative, low-cost alternative to high tech medical devices has huge potential to impact women’s lives in low-income regions. For lay readers, though, the news release promises a little bit more than the evidence yet warrants.
The news release indicates that the pocket colposcope will be much less expensive than current equipment, although no specific numbers are provided. The omission is unfortunate, since the study it’s based on does provide cost estimates, citing a cost of $54 for the camera and $1 for the inserter. This device also requires the availability of a cell phone or laptop, and, at least for the present, images must still be read by a trained technician. We don’t know how much savings the device will generate, and it’s difficult to estimate how feasible it will be for low-resource clinics domestically or internationally. It’s true the device is at an early stage of testing, but more information would have been helpful.
The cost saving of this innovation is the main benefit touted, but it’s not quantified. The release does speak to the usability of the device when quoting one of the researchers who describes the experience of 15 university volunteers who tried the device. She says that “more than 80 percent of the women who tried the device were able to get a good image.” But what exactly “a good image” means is not explained. (Is it good enough for an accurate diagnosis?) The release does state that trials are planned to compare the new device with the traditional colposcope, but it should have been clearer about the fact that the device’s accuracy has not been objectively assessed.
No possible harms are described. While it is difficult to imagine how this device could cause direct harm, screening and diagnostic tests always involve the possibility of harm from false-negative and false-positive tests. A brief mention of this was warranted.
The report on this innovation was published in a highly respected, peer-reviewed journal. At the same time, this news release passes a bit too quickly over the limitations of what is known about its effectiveness. No clinical trials have yet demonstrated the sensitivity and specificity of the device in comparison with current standard practice. What we know is that 12 of 15 highly educated young volunteers were able to produce usable images with it. Three of 15 volunteers were unsuccessful, although they said they thought more practice would help. This degree of user friendliness is perhaps promising, but the campus of an elite American university is not the type of low-resourced setting for which the pocket colposcope is designed. We can’t be sure that less educated women would be able to use the device with even an 80 percent success rate. Successful use of the device for diagnosis also depends upon either the presence of trained medical personnel to read the images — something which cannot be assured in disadvantaged communities — or on as-yet nonexistent automated screening procedures.
There is no disease mongering in this release. It provides ample context on cervical cancer incidence and tests used in its diagnosis.
The release acknowledges in a footnote that the research was funded by the National Institutes of Health. That’s enough to meet our standard, but putting this information in the body of the release would make it more likely to be picked up by syndicators and others who might redistribute this content.
There is some description of current standard screening practices, and several failed attempts at lower-cost alternatives to traditional practice are briefly mentioned. However, we are rating this Not Satisfactory for several reasons. First, there is confusion about the role of colposcopy; it is not a primary screening tool, but rather a method for further evaluation of women with an abnormal screening test for cervical cancer. Colposcopy is an essential part of any screening program, to be sure, but it is not generally seen as feasible or effective as a primary screening test. Second, cervical cancer screening methods in resource-poor settings have been actively studied and several alternatives to standard Pap smears exist. These include HPV testing (a rapid HPV test is under development using a self-collected sample) and visual inspection after acetic acid application.
The release does not clearly state that the device is currently unavailable. Savvy readers may glean this from the description, but a more direct statement and discussion of the steps involved before the device can be commercially produced and used would have been helpful.
The article states that the device is the first of its kind. We agree that the inserter is a novel device as an alternative to the speculum. Its use together with the digital colposcope is also a novel concept.
No unjustifiable language was noted.
Systematic, Criteria-Driven
The tale of two “negative” studies. Or, how spin is applied to make research findings look more impressive. A must read. https://johnmandrola.substack.com/p/the-tale-of-two-negative-studies
The @nytimes chose to interview one of the editors of the @AnnalsofIM (publisher of this paper) who "gushed with extraordinary glee: It’s huge! There are very few things that reduce your mortality by 30%."
Turns out coffee is not one of those few things despite all that glee. https://twitter.com/garyschwitzer/status/1533202075928215558
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